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How to correctly understand GMP How to build a GMP laboratory for pharmaceutical companies CEIDI

文章出处:Technology|阅读量:410|发表时间:2021-03-09

Many people only know GMP, but don't understand its true meaning. Let's follow CEIDI to understand the meaning of GMP correctly today. The full name of GMP (GOOD MANUFACTURING PRACTICES), the Chinese meaning is "manufacturing quality management practices" or "good operating practices", "good manufacturing standards". It is a set of compulsory standards applicable to the pharmaceutical, food and other industries. It requires companies to meet the hygienic quality requirements in accordance with relevant national laws and regulations in terms of raw materials, personnel, facilities and equipment, production processes, packaging and transportation, and quality control. The operating specifications of the company help companies improve the sanitary environment of the company, discover problems in the production process in time, and make improvements.

Simply put, GMP is a mandatory standard specification. To meet the requirements of this specification, pharmaceutical, food and other manufacturing companies are required to have good production equipment, reasonable production processes, perfect quality management and strict inspection systems to ensure that the quality of the final product (including food safety and hygiene, etc.) meets the laws and regulations Claim. Knock on the blackboard to draw the key points. Many people think that GMP is the standard specification for the pharmaceutical and food industries. In fact, it is not always true. GMP is a criterion that must be implemented in the pharmaceutical and food industries. There are also many industries at the moment. For example, the cosmetics industry is also moving towards GMP standards to organize the construction of production research and development bases for related technical reforms, and use this as a necessary basis to complete the national "CFDA" filing and listing process. But in the field of pharmaceutical production, the requirements for GMP are absolute and compulsory standards. From hardware and software upgrades to the completion of the new version of GMP certification, although there is a long way to go, it is a process that it must go through. This also corresponds to the wave of large-scale upgrading and transformation of my country's pharmaceutical companies since the implementation of the "Good Manufacturing Practice for Pharmaceutical Production (Revised in 2010)" (hereinafter referred to as the new GMP) since March 1, 2011.

For pharmaceutical companies, building a workshop (factory area) that meets GMP standards is the first step and one of the most important links to achieve GMP standards. It is not difficult to explain why we often see GMP workshops used as a synonym for production workshops of pharmaceutical companies. But what CEIDI needs to convey here is: reaching GMP standards is a systematic work, which includes building decoration, facility configuration, personnel management, equipment management, document management, production management, quality control, material management, shipping and Parallel execution process of each link such as recall and self-inspection management. When we cooperate with many pharmaceutical companies, we not only plan, design, and decorate production workshops for them, and configure laboratories/clean rooms of appropriate scale and standards in the workshops, but also use our professional experience with the R&D directors and QCs of the pharmaceutical companies. In-depth discussion on the management content of GMP. This is one of the reasons why CEIDI Xidi has up to 75% of old customers.

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